Electronic data document for use in clinical trial verification system and method

• US 10,706,958 B2
• Filed: 04/06/2016
• Issued: 07/07/2020
• Est. Priority Date: 11/20/2015
• Status: Active Grant

• Current Assignee: Ikeguchi Holdings, LLC
• Original Assignee: Ikeguchi Holdings, LLC
• Inventors: Ikeguchi, Edward, Henderson, James
• Primary Examiner(s): Augustine, Victoria P
• Assistant Examiner(s): Williams, Teresa S
• Application Number:
  US15/092,152
• Publication Number:
  US 20170147792A1
• Time in Patent Office: 1,553 Days
• Field of Search: 705 2, 705 3, 715205
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

Abstract

The present invention provides an electronic data document (EDD) and related system and method for use in a computerized clinical trial verification system. In an exemplary embodiment, the EDD is authenticated by the creator and validated by the receiver, and comprises an image of a source document (SD) that comprises a masked record of at least one interaction between a clinical trial investigator and a patient enrolled in a clinical trial, at least one revealed portion of the SD that includes evidence relevant to at least one question in a clinical trial questionnaire, and at least one annotation connecting the revealed portion to the at least one question. The present invention provides a computerized system and method for allowing a clinical trial investigator to answer questions from a clinical trial questionnaire pertinent to a clinical trial of a medical treatment using encrypted and partially masked electronic documents comprising images of original patient records. The process of creating and viewing the partially masked electronic documents preferably does not create local copies that can be recalled later.

Claims

1. An electronic data document (EDD) in a non-transitory computer-readable medium for use in a computerized clinical trial verification system, the system comprising a first computer program that can be used by a clinical trial investigator to create the EDD and a second computer program that can read and modify the EDD, the EDD comprising:

integrated computer instructions that are compatible with the first computer program and the second computer program and integrated with the EDD;

at least one screenshot capture obtained directly from a source document (SD) for an official electronic medical records system, wherein the screenshot capture consists of at least a portion of the source document, the source document comprising a record of at least one interaction between the clinical trial investigator and a patient enrolled in a clinical trial, the at least one screenshot capture used to directly answer at least one question from a clinical trial questionnaire;

wherein the integrated computer instructions further comprise;

first computer instructions that permit a receiver of the EDD to validate a sender of the EDD and an electronic data structure of the EDD;

second computer instructions that permit the clinical trial investigator to select and label information for answering the at least one question from a clinical trial questionnaire that is included in the screenshot capture;

third computer instructions that mask from view by the receiver all of the information not selected and labeled in the screenshot capture, such that the receiver can view only the selected and labeled information in the screenshot capture and the masked information is retained as part of a redacted screenshot capture;

fourth computer instructions that permit one or more authorized users of the second computer program to modify the EDD to show that the selected and labeled information of the screenshot capture is acceptable evidence to answer the at least one question from the clinical trial questionnaire; and

fifth computer instructions that include a patient ID or other additional patient information as part of the EDD.

2. The EDD of claim 1 wherein the computer instructions further comprise sixth computer instructions that permit the one or more authorized users of the second computer program to selectively view one or more parts of the redacted screenshot capture.

3. The EDD of claim 1, wherein the EDD is encrypted using a public/private key pair.

4. The EDD of claim 1 wherein the computer instructions further comprise seventh computer instructions that permit the clinical trial investigator to modify the EDD to associate an electronic signature with the EDD.

5. The EDD of claim 1 wherein the second computer program cannot save a copy of the EDD locally as a file that can be recalled at a later time.

6. The EDD of claim 1 wherein the computer instructions further comprise eighth computer instructions that permit the clinical trial investigator to modify the EDD to associate an electronic signature with the selected and labeled information of the at least one screenshot capture.

7. The EDD of claim 1 wherein each of the questions of the clinical trial questionnaire is answered using at least one screenshot capture.

8. The EDD of claim 1 wherein the patient ID or other additional patient information is embedded in the screenshot capture of the SD.

9. The EDD of claim 1 further comprising additional digital media imported from an external source.

10. The EDD of claim 9 wherein the additional digital media consists of a photograph of a paper document or a medical scan other information that cannot be captured with a screenshot.